Intraocular melanocytoma in association with bone formation.

as a medical device by the Food and Drug Administration in the United States. This enzymatic cleaner is “generally regarded as safe” by the Food and Drug Administration and the European Medical Evaluation Agency. Nevertheless, serious adverse ocular effects frequently do not come to the attention of government regulators until a product is marketed to the public, owing to the limited number of subjects exposed during the developmental phase. Although the adverse ocular reaction was immediate in all reported cases, the symptoms resolved within 24 hours in 6 of the 7 subjects for whom data were recorded. There are no dechallenge data (resolution of the adverse reaction when stopping the medication) available in the remaining 8 case reports. The incidence of these adverse ocular reactions is difficult to predict with the passive data collection method used here. Conclusions about the exact incidence of drug-induced reactions are generally not possible unless costly follow-up with potentially millions of patients is undertaken. In general, if an adverse ocular reaction occurs when these products are used, copious irrigation with water is recommended and follow-up with an ophthalmologist should occur if symptoms persist for more than 24 hours. It is suggested that these recommendations be included in the package insert. All case reports regarding these ocular reactions, as well as any impressions regarding other medications, can be submitted online at http://www.eyedrugregistry.com. Case reports may also be faxed or mailed to the National Registry of Drug-Induced Ocular Side Effects, 3375SW Terwilliger Blvd, Portland, OR 97201 Fax: (503)494-4286.